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Knee Osteoarthritis, Kinesiophobia and Physical Activity

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ClinicalTrials.gov Identifier: NCT03875040
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Melek Aykut Selçuk, Aksaray University Training and Research Hospital

Study Description
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Brief Summary:
Although the importance of regular physical activity in patients with knee osteoarthritis is known, and fear of movement is considered as one of the causes of physical inactivity and is widely researched in terms of its role in the pathogenesis of pain, there remains to be limited number of studies on kinesiophobia in these patients. In this study, we aimed to evaluate the levels of kinesiophobia and physical activity in patients with knee osteoarthritis and to investigate whether they were associated with demographic characteristics, body mass index, pain intensity, depression, disability, radiological grade, and quality of life.

Condition or disease Intervention/treatment
Fear of Pain Knee Osteoarthritis Physical Activity Behavioral: kinesiophobia

Detailed Description:
A total of 96 female and male patients aged 50 to 75 years with knee osteoarthritis (OA) and knee pain lasting for more than three months (knee pain intensity over 20 mm on Visual Analog Scale-VAS) were included in the study. The severity of pain at night, pain at rest and activity-related pain was evaluated by Visual Analog Scale (VAS), kinesiophobia by Tampa Scale of Kinesiophobia (TSK) and Brief Fear of Movement Scale (BFOM), depression by the Beck Depression Inventory (BDI), disability by the Western Ontario and McMaster Universities Arthritis Index (WOMAC), physical activity level by the International Physical Activity Questionnaire (IPAQ) short form and quality of life by the Short Form 12 Health Survey Questionnaire (SF-12). Age, gender, marital status, educational status, additional disease, drug history, and sociodemographic data such as BMI were obtained from the patients and recorded in the evaluation form.
Study Design
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Study Type : Observational
Actual Enrollment : 96 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Is There a Relationship Between Kinesiophobia and Physical Activity Level in Patients With Knee Osteoarthritis?
Actual Study Start Date : April 20, 2018
Actual Primary Completion Date : October 20, 2018
Actual Study Completion Date : October 20, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Behavioral: kinesiophobia
    patients who have a high-level or low-level kinesiophobia have been evaluated.

Outcome Measures
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Primary Outcome Measures :
  1. Tampa Scale of Kinesiophobia [ Time Frame: 4-8 minutes ]
    Based on a four-point Likert type, this scale contains 17 items that evaluate fear and anxiety related to physical activity. A total score of greater than 37 is accepted as statistically significant and interpreted as a high level of kinesiophobia. Minimal and maximal scores could be between 17-68 points. Higher scores indicate higher levels of kinesiophobia.

  2. International Physical Activity Questionnaire Short Form [ Time Frame: 5-10 minutes ]
    This questionnaire consists of seven items that measure the duration of the participants' physical activity, walking and sitting within the last seven days in the metabolic equivalent (MET)-min/week unit. 3 or more days of vigorous activity of at least 20 minutes per day or 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day or 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-minutes/week are proposed to be moderate level. Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week or 7 or more days of any combination of walking, moderate- or vigorous-intensity activities accumulating at least 3000 MET-minutes/week are proposed to be high level.Some activity is reported but not enough to meet categories of moderate or high levels, it is proposed to be low level.

  3. Beck Depression Inventory [ Time Frame: 10 minutes ]
    This is a 21-item questionnaire that investigates the characteristic attitudes and symptoms of depression. A score of 10 or higher indicates depression. Minimal and maximal scores can be 0-63 points. Higher scores indicate higher levels of depression.

  4. Visual Analog Scale for the Evaluation of Pain [ Time Frame: 0.5 minutes ]
    For this evaluation, the patient is asked to mark his/her severity of pain on a horizontal 10-cm line with number 0 on one end representing "no pain" and number 10 on the other end indicating "very severe pain". Higher scores indicate higher levels of pain intensity.

  5. Short Form-12 Health Survey Questionnaire [ Time Frame: 5 minutes ]
    A scale used to evaluate the quality of life, consisting of 12 items inquiring general health, physical condition, physical limitations, mental status, social status, pain, energy and mental limitation over a total score of 100 points. SF-12 is an abbreviated version of SF-36 and has been proven to be reliable and valid. In this study, we evaluated the patients' total, physical and mental SF-12 scores

  6. Western Ontario and McMaster Universities Arthritis Index [ Time Frame: 10 minutes ]
    A 24-item measure that was developed to evaluate pain, joint stiffness and physical functions in individuals with knee and hip OA. A higher score indicates a higher level of pain, stiffness and functional limitation. In our study, we used the WOMAC total score.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All the patients presenting to Aksaray Training and Research Hospital Physical Medicine and Rehabilitation Outpatient Clinic between April 2018 and October 2018, who volunteered to participate in the study and fulfilled the inclusion criteria, completed the questionnaire forms.
Criteria

Inclusion Criteria:

knee osteoarthritis aged 50 to 75 years knee pain lasting for than three months knee pain intensity over 20 mm on Visual Analog Scale-VAS

Exclusion Criteria:

knee operation, Malignant diseases Systemic infectious diseases inflammatory diseases Fibromyalgia syndrome physical therapy and/or a knee injection within the last three months antidepressants, pregabalin or duloxetine usage

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03875040


Locations
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Turkey
Aksaray Training and Research Hospital
Aksaray, Merkez, Turkey, 68200
Sponsors and Collaborators
Aksaray University Training and Research Hospital
Investigators
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Principal Investigator: Melek Aykut Selçuk Ankara Akyurt Public Hospital
  Study Documents (Full-Text)

Documents provided by Dr. Melek Aykut Selçuk, Aksaray University Training and Research Hospital:
Study Protocol and Statistical Analysis Plan  [PDF] March 19, 2019

More Information
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Publications:

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Responsible Party: Dr. Melek Aykut Selçuk, Principal investigator, Aksaray University Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03875040    
Other Study ID Numbers: 2018/67
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Melek Aykut Selçuk, Aksaray University Training and Research Hospital:
kinesiophobia
osteoarthritis
fear of movement
tampa
physical inactivity
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases